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    K Number
    K191774
    Device Name
    SmileAlign Orthodontic Aligner System
    Manufacturer
    3D Global Biotech Inc.
    Date Cleared
    2019-09-30

    (90 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D Global Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.
    Device Description
    The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
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